Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

Официальное название

Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study

Обзор

This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI\<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.

Вмешательства

• Другое cytoreductive surgery
  Open surgery is conducted by senior doctors in gynecological oncology. The following parameters should be recorded: period of operation, location and number of recurrent lesions, location and number of resected lesions, amount of intraoperative bleeding and blood transfusion, whether R0 is reached, size and distribution of residual lesions, surgical complications, hospital stay, and period to adjuvant chemotherapy. Patients are required to start intravenous chemotherapy within 4W after surgery,

Первичные конечные точки

• PFS [Срок оценки: month 6]

Критерии участия

Критерии включения

• Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;
• Recurrence occurred within 6 months since platinum-based chemotherapy;
• R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;
• ECOG/WHO Performance score of 0 to 1;
• Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
• No Renal insufficiency: serum creatinine < 1,5 time the normal limit, creatinine clearance > 60 mL/min;
• No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;
• Patients with good compliance;
• Patients having read, signed and dated Informed consent before any study procedure.

Критерии исключения

• Platinum-refractory/uncontrolled epithelial ovarian cancer;
• Mucous carcinoma or low-grade serous carcinoma;
• Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
• Patients have received abdominal or pelvic radiotherapy;
• General conditions cannot tolerate cytoreduction;
• Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;
• Unable or unwilling to sign the informed consent form;
• Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Women's Hospital, Zhejiang University School of Medicine — Ханчжоу
• Women's Hospital, Zhejiang University School of Medicine — Ханчжоу

Публикации

• Chen T, Xu J, Xia B, Wang H, Shen Y. Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study. J Gynecol Oncol. 2024 Jan;35(1):e22. doi: 10.3802/jgo.2024.35.e22. Epub 2023 Oct 30. PMID 37945326

Идентификаторы

NCT: NCT05633199 · CSPROC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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